unresectable advanced or recurrent solid tumors
Conditions
Interventions
Administration of ONO-7428
Sponsors
Terasawa Tetsuji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants with histologically or cytologically confirmed unresectable advanced or recurrent solid tumors. [Backfill cohort only] Participants with histologically or cytologically confirmed Stage IIIB, IIIC, IV, or recurrent NSCLC according to UICC-TNM classification . 2. Participants who are refractory or intolerant to standard therapy. 3. Participants with a tumor type for which anti-PD-(L)1 antibodies have been approved and who have previously treated with anti-PD-(L)1 antibody containing regimen. 4. Participants with Eastern Cooperative Oncology Group Performance Status 0 or 1. 5. Participants with tumor tissue samples available for biomarker testing.
Exclusion criteria
Exclusion criteria: 1. Participants with a complication or history of severe hypersensitivity to any other antibody drugs. 2. Participants with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease 3. Participants with severe peritoneal dissemination. 4. Participants with pericardial fluid, pleural effusion, or ascites requiring treatment. 5. Participants with uncontrolled tumor-related pain. 6. Participants with active or history of interstitial lung disease or pulmonary fibrosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerability, safety | — |
Contacts
Public ContactSupport Desk JP
Ono Pharmaceutical Co.,LTD
Outcome results
None listed